Drug Enforcement D-0484-2024

CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit

Status

Ongoing

Classification

Class II

Report Date

May 15, 2024

Termination Date

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Product Information

Product description
Duloxetine Delayed-Release Capsules, USP, 60 mg, 90-count bottles, Rx Only, Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Dist. by: Breckenridge Pharmaceuticals, Inc., Berkeley Heights, NJ 07922, NDC: 51991-748-90.
Product quantity
281,554/90 count bottles
Reason for recall
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
Recall initiation reason
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Initial firm notification
Letter
Distribution pattern
US Nationwide.

Location & Firm

Recalling firm
Breckenridge Pharmaceutical, Inc
Address
15 Massirio Dr Ste 201, N/A

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date
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Codes & Dates

Recall number
D-0484-2024
Event ID
94483
Recall initiation date
April 29, 2024
Center classification date
May 4, 2024
Code info
230028C: Exp. Nov 2025 230106C: Exp. Dec 2025 230170C: Exp. Dec 2025 220039: Exp. Dec 2024 220363: Exp. Feb 2025
More code info
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